Additive Effects of Dental Bite Pads During Gymnastic Exercises for the Relief of Chronic Non-specific Neck Pain in Working Women and Men at a VDU Workplace
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Neck pain (NRS)
研究概览
简要总结
The study which includes 52 participants suffering from chronic neck pain, determines additional effects of dental bite pads on neck pain and function when performing a 3-month gymnastics programme.
详细描述
Chronic neck pain is a common health problem in our society. Targeted gymnastic exercises have a high priority in the context of therapy and have shown positive effects on the symptoms in studies. In the past, direct connections between the temporomandibular joint and complaints of the musculoskeletal system, especially of the shoulder-neck region, have been researched, which are based on neuroanatomical (nerves) and myofascial (muscle-fascia) connections. Against the background of current study results, consideration of these findings could be promising in the therapy of neck pain. A new approach tries to positively influence tension and discomfort in the neck area by changing the position of the temporomandibular joints using dental bite pads. In the planned study, the researchers are specifically investigating the question of the extent to which the placement of dental bite pads (made of silicone) in the molar region during the performance of gymnastic exercises can increase the effect of the exercises on neck pain and the associated restrictions on function and quality of life.
The aim of the present project is specifically to record the effect of a 3-month gymnastics programme and a possible additional effect of dental bite pads. In the study, 52 working women and men with a sedentary job at a computer workstation aged 30-65 years are included and randomly divided into two groups. Both groups will perform a specific video-animated exercise programme for 3 minutes 3 times a day over a period of 3 months with the main focus on the shoulder-neck region. One group positions a silicone dental bite pad (TJ Motion; BELY Balance GmbH & Co. KG, Weisendorf, Germany) on the right and left side of the molar region during the exercise.
Before the intervention, after 6 weeks and after a further 6 weeks of follow-up, pain and function in the neck area are assessed by questionnaire. At baseline and follow-up, functional tests of spinal and jaw mobility are also performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Computer-assisted block randomisation (stratification according to pain intensity) is carried out by an independent statistician. The blinding of the study refers to the measurement assistants who do not know/are not allowed to ask about the respective status of the participant.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 30-65 LJ
- •Chronic non-specific neck pain [4] (at least for 3 months, pain intensity ≥2 (NRS) on at least 50% of days).
- •Sedentary work, VDU work
排除标准
- •Specific neck pain (e.g. herniated disc, spinal stenosis, etc.)
- •Cervical spine-related neuronal symptoms (paresthesia, brachialgia, paresis)
- •Continuous pain medication
- •Concurrent other therapy to influence neck pain
- •Absence ≥ 2 weeks during the intervention period
- •Regular sports training (≥ 60min/week) in the last 6 months
研究组 & 干预措施
gymnastic (control group)
"usual care" home gymnastics programme for 12 weeks, which consists of three different 3-minute sequences to be performed daily.
干预措施: gymnastics only (Other)
gymnastic plus dental bite pads (intervention group)
Identical home gymnastics programme for 12 weeks, which consists of three different 3-minute sequences to be performed daily plus dental bite pads during exercise. The dental bite pads are placed on the back molars of the lower jaw and remain in this position in the mouth for 3 minutes during the exercise.
干预措施: gymnastics plus silicon dental bite pad (Device)
结局指标
主要结局
Neck pain (NRS)
时间窗: Baseline, 6 Weeks, 12 Weeks
Neck pain. The numerical rating scale (NRS) is a one-dimensional pain scale with which patients can quantify their subjectively felt pain. To do this, the patient is asked to assign their pain to a scale of 0-10. "10" stands for "strongest pain imaginable", "0" for "no pain". The recording is done every evening via a pain diary, in each case for one week, before the start of the intervention and in the 6th and 12th week of the intervention. The pain intensity as the primary endpoint is defined as the mean value over one week.
次要结局
- Shoulder mobility(Baseline, 12 Weeks)
- kyphosis angle(Baseline, 12 Weeks)
- Mobility of the cervical spine (range of motion (ROM))(Baseline, 12 Weeks)
- TMD symptoms (questionnaires)(Baseline, 12 Weeks)